OBJECTIVE: To evaluate the efficacy, target population and influencing factors of Gefitinib in patients with non-small-cell lung cancer (NSCLC) pretreated with platinum. METHODS: Patients with NSCLC who had been previously treated with at least one course of platinum based chemotherapy received 250 mg oral doses of Gefitinib once daily till disease progression. Response rate, progression free survival, overall survival and toxicity profile were analyzed. Kaplan-Meier method was used to analyze the survival rate. Cox regression was used to define the predictive factors. RESULTS: A hundred and fifteen patients were enrolled into the study from July 2001 to May 2005. The follow-up was ended on Sep. 30, 2006. Median follow up time was 30 months. The compliance rate was 100%. The median symptom improving time was 8 days. Complete response rate was 4.3% (5/115), partial response 39.1% (45/115), stable disease 27.0% (31/115) and progressive disease 29.6% (34/115). Response rate was 43.5% (50/115). Disease control rate was 70.4% (81/115). The median progression-free survival and median overall survival were 8 and 11 months, respectively. One and two-year progression-free survival rates and overall survival rates were 32.2% (events 78), 5.6% (events 103) and 41.7% (death 67), 21.5% (death 87) respectively; 3-year overall survival 12.3% (death 93). Adenocarcinoma was the only predictor for therapeutic effect in the Cox model (P = 0.004). The primary failure to gefitinib was due to brain metastasis (39.4%, 28/71). Grade III skin toxicity was found in 5.2% (6/115) patients. CONCLUSION: Gefitinib is the drug of choice for patients with heavily pretreated stage III(B) and IV adenocarcinoma of NSCLC with safe and accepted toxicity profile.
OBJECTIVE: To evaluate the efficacy, target population and influencing factors of Gefitinib in patients with non-small-cell lung cancer (NSCLC) pretreated with platinum. METHODS:Patients with NSCLC who had been previously treated with at least one course of platinum based chemotherapy received 250 mg oral doses of Gefitinib once daily till disease progression. Response rate, progression free survival, overall survival and toxicity profile were analyzed. Kaplan-Meier method was used to analyze the survival rate. Cox regression was used to define the predictive factors. RESULTS: A hundred and fifteen patients were enrolled into the study from July 2001 to May 2005. The follow-up was ended on Sep. 30, 2006. Median follow up time was 30 months. The compliance rate was 100%. The median symptom improving time was 8 days. Complete response rate was 4.3% (5/115), partial response 39.1% (45/115), stable disease 27.0% (31/115) and progressive disease 29.6% (34/115). Response rate was 43.5% (50/115). Disease control rate was 70.4% (81/115). The median progression-free survival and median overall survival were 8 and 11 months, respectively. One and two-year progression-free survival rates and overall survival rates were 32.2% (events 78), 5.6% (events 103) and 41.7% (death 67), 21.5% (death 87) respectively; 3-year overall survival 12.3% (death 93). Adenocarcinoma was the only predictor for therapeutic effect in the Cox model (P = 0.004). The primary failure to gefitinib was due to brain metastasis (39.4%, 28/71). Grade III skin toxicity was found in 5.2% (6/115) patients. CONCLUSION:Gefitinib is the drug of choice for patients with heavily pretreated stage III(B) and IV adenocarcinoma of NSCLC with safe and accepted toxicity profile.